jeri d. ropero-miller, ph.d., d-abft - substance abuse and ...€¦ · oral fluid pilot pts (2006...
TRANSCRIPT
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Hair Proficiency Testing
Jeri D. Ropero-Miller, Ph.D., D-ABFT Drug Testing Advisory Board
Open Session
July 15, 2013
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Objectives
●Design and Results of SAMHSA’s Hair Pilot Proficiency Testing (PT) Program, 2000 to 2007
●Design and Results of Society of Hair Testing (SoHT) Hair Proficiency Testing Program, 1995-present
●Design of Other Hair Proficiency Testing Programs
Proficiency Testing 2 July 15, 2013
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Background SAMHSA’s Pilot Hair PT Program
● April 1997, DTAB meeting discussed drug testing in alternate matrices
● Duration: 2000-2007 ● Up to 13 laboratories participated ● 23 cycles of samples tested
• Cycles 1-8: Method Optimization • Cycles 9-11: Same samples over 6 months • Cycles 12-23: Inter- and intra-lab variability
Proficiency Testing 3 July 15, 2013
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Background SAMHSA’s Pilot Hair PT Program
● Important finding was a large variation in reported results
● 2006-2007 PT samples evaluated laboratory variability and sample stability
Proficiency Testing 4 July 15, 2013
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Design of Pilot PT Program 2007
● 6 or 7 participant laboratories ● Laboratories investigated
accuracy and precision ● Single PT production
• Decontaminated hair samples in PT production
• Authentic hair fortified with drug analytes or known drug users
• Stored ambient temperature prior to shipments
Proficiency Testing 5 July 15, 2013
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Design of Pilot PT Program (Continued)
● Three sample sets sent to each lab over 1 year (0, 3, 6, 12 months)
● Concentrations were 1.5 to 3 times the 2004 proposed confirmatory test cutoffs
● Laboratories quantitated each analyte 5 times in multiple batches
Proficiency Testing 6 July 15, 2013
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Design of Pilot PT Program (Continued)
● Set 1 (pg/mg):
• THCA (0.82)* • THCA (0.15) • AMP/MAMP/MDA/MDEA/MDMA (900) • AMP/MAMP/MDA/MDEA/MDMA (450)
● Set 2 (pg/mg):
• COC (5770)/BE (2547)/CE(54 )/ NCOC (85)* • COC (750)/NCOC (75)/CE (75) • COC (1500) • BE (75)
Proficiency Testing 7 July 15, 2013
*Drug User Hair
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Design of Pilot PT Program (Continued)
● Set 3 (pg/mg):
• 6-AM (1411)/MOR (630)/COD (183)* • 6-AM/MOR/COD (600) • 6-AM/MOR/COD (300) • PCP (450)
● No decontamination ● Confirmatory testing only
Proficiency Testing 8 July 15, 2013
*Drug User Hair
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NLCP Pilot Hair PT Methods
● Deuterated internal standards ● Not all analytes reported by all labs ● Powdering vs Strands ● Pre-Treatment Techniques
• None/DI H2O/Solvent (MeOH/MeCl2/Acetone) ● Digestion Techniques
• None/Acidic/Basic/Enzymatic ● Extraction Techniques
• L/L andSPE Proficiency Testing 9 July 15, 2013
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NLCP Pilot Hair PT Confirmatory Testing
● Confirmatory Testing ● Quantitation and identification
by a confirmatory mass spectrometry method
● PT result reports with group statistics sent to each lab for self-assessment
Proficiency Testing 10 July 15, 2013
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Proficiency Testing 11 July 15, 2013
(pg/mg) AMP (450)
MAMP (450)
MDA (450)
MDMA (450)
MDEA (450)
THCA (0.15)
0 months (Cycle 1) 397 411 421 316 278 0.17
3 months (Cycle 2) 463 493 460 397 432 0.16
6 months (Cycle 3) 436 469 467 399 398 0.15
12 months (Cycle 4) 449 481 455 408 412 0.13
Mean ± SD 436 ± 29 464 ± 36 451 ± 20 380 ± 43 380 ± 69 0.15 ± 0.02
Laboratory Pilot Hair PT Results:2007
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Proficiency Testing 12 July 15, 2013
2007 Pilot Hair PT Results: AMPS
Lab
Mea
n Co
ncen
trat
ion
Mea
sure
d (p
g/m
g)
QMLGE
1200
1100
1000
900
800
700
600
500
Cycle
1821
1215
Interaction Plot Means--Lab vs Cycle
Target: MAMP 900 pg/mg
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Lab
Mea
n Co
ncen
trat
ion
Mea
sure
d (p
g/m
g)
MLGE
750
700
650
600
550
500
Cycle2
1922
1316
Interaction Plot Means--Lab vs Cycle
Proficiency Testing 13 July 15, 2013
2007 Pilot Hair PT Results: COC
Target: COC 750 pg/mg
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Lab2
Mea
n Co
ncen
trat
ion
Mea
sure
d (p
g/m
g)
QMG
0.26
0.24
0.22
0.20
0.18
0.16
0.14
0.12
0.10
Cycle2
1821
1215
Interaction Plot Means--Lab by Cycle
Proficiency Testing 14 July 15, 2013
2007 Pilot Hair PT Results: THCA
Target: THCA 0.15 pg/mg
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System Variance Over 1 Year by Cycle
Proficiency Testing 15 July 15, 2013
10%
Mean %CV
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
AMP 900
AMP 450
MAMP 900
MAMP 450
MDA 900
MDA 450
MDMA 900
MDMA 450
MDEA 900
MDEA 450
THCA 0.82
THCA 0.15
Analyte and Concentration (pg/mg)
0 months (Cycle 1) 3 months (Cycle 2) 6 months (Cycle 3) 12 months (Cycle 4) Urine (2004-2005)*
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System Variance Over 1 Year by Cycle
Proficiency Testing 16 July 15, 2013
0
5
10
15
20
25
30
35
6AM COD MOR PCP THC / THCA AMP MAMP BE
%C
V
Hair Pilot PTs (2006-2007)
Oral Fluid Pilot PTs (2006-2007)
Urine NLCP Maintenance PTs (2006)
10%
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Summary 2006 Pilot PT Program
● Stable material for all drugs over 1 year ● Results for the system of participating hair-testing
laboratories are not currently consistent ● For some analytes, there was increased variability
in results after 1 year, illustrative of the laboratory challenge of maintaining performance
● Material performed well for all analytical methods
Proficiency Testing 17 July 15, 2013
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SOCIETY OF HAIR TESTING HAIR PROFICIENCY PROGRAM
Proficiency Testing 18 July 15, 2013
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Background Society of Hair Testing (SoHT)
● “…development of proficiency tests (PTs), so that all laboratories which perform hair analysis can produce comparable results, or at least detect the same compounds” (Forens Sci Intl, 2003)
● Voluntary Program ● PT Rounds
• 18-36 participating laboratories • 1995, 1997, 2001, 2007-2012 (2) • 2008, 2009, 2010 (EtG Special PT) • Qualitative and Quantitative results
Proficiency Testing 19 July 15, 2013
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Design of SoHT PT Program - 2001
● Goals • Accuracy of Detection and Quantification • Performance of Extraction Methods
● 15 Participating Labs & 3 Reference Labs ● Samples
• Short Hair Segments • Drug User Hair- COC, BE, MDMA, MDEA, THC • Drug User Hair- COC, BE, 6AM, MOR, COD, DHC • Drug Free Hair
Proficiency Testing 20 July 15, 2013
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Results for SoHT Hair PT Program- 2001
● Not all analytes reported by all labs • Amphetamines- 8 • Cannabis- 9
● Qualitative results • False Negatives- 1 (BE, 6AM, MOR), 3 (COD) • False Positive- 1 (COD, 6AM)
● Quantitative results • Mean inter-laboratory %CVs 41.7% to 71%
except THC (93.1%) • Extraction procedures source of variation
Proficiency Testing 21 July 15, 2013
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Design of SoHT PT Program - 2011
● Goals • Accuracy of Detection and Quantification
● 36 Participating Labs & 3 Reference Labs ● Samples
• Short Hair Segments • Drug User Hair- COC, BE, 6AM, MOR, COD, THC • Drug User Hair- COC, BE, MAMP, THC • Drug Free Hair
Proficiency Testing 22 July 15, 2013
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Results for SoHT Hair PT Program- 2011 ● Z-score (Z-score = (x - χ) / IQR
• Satisfactory (>2.0) • Questionable (2 < Z-score ≤ 3) • Unsatisfactory (≥3.0)
● Quantitative results- Sample 1 • 6-AM: 2 Not analyzed; 1 questionable • MOR: 1 Not analyzed; 1 questionable • COD: 13 Not analyzed or Neg; 1 unsatisfactory • THC: 10 Not analyzed or Neg; 1 unsatisfactory
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Results for SoHT Hair PT Program- 2011 ● Quantitative results-
• COC: 1 Not analyzed; 2 questionable • BE: 4 Not analyzed • MAMP: 7 Not analyzed or Neg; 1 questionable
● Mean inter-laboratory %CVs 34% to 55% except COD (306%)
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● Worldwide 5 Hair PT Programs ● Professional and governmental programs ● Hair PT Programs
• GTFCh- German Society of Toxicological and Forensic Chemistry (late 1990s to Present)
• HAIRVEQ- Germany and Spain (2004, 2006)
• NLCP- National Laboratory Certification Program (2000-2007)
• SFTA- French Society of Analytical Toxicology (1992-1999)
• SoHT- Society of Hair Testing (1995 to Present)
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Comparison of Hair PT Programs
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Proficiency Testing 26 July 15, 2013
Hair PT Program Hair Type PT Type Analytes Conc. Washing Preparation
GTFCH Authentic
Spiked; Drug User
All but PCP; +THC (addition of further analytes possible)
≥ SAMHSA PCP: NR
Not Reported Also powdered Lab Choice
HAIRVEQ Authentic
Drug User
opiates, cocaine, MDMA, and methadone
≥ SAMHSA PCP: NR
Not Reported Also powdered
Lab Choice; Standardized
SFTA Authentic
Drug User All but PCP; +CBD
≥ SAMHSA PCP: NR
Step in PT Production Standardized
SoHT Authentic Drug User All but PCP; +THC
≥ SAMHSA PCP: NR Not Reported Lab Choice
NLCP
Authentic
Spiked; Drug User
AMP/MAMP MDA/MDMA/MDEA COC/BE COD/MOR/6AM THCA PCP
AMP: 200 COC: 500 OPI: 200 THCA: 0.05 PCP: 300
Step in PT Production Lab Choice
Comparison of Hair PT Programs
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Conclusions
● Performance Testing is a necessary quality control measure
● Results for the systems of participating hair-testing laboratories are not currently consistent
● Inter-laboratory and Intra-laboratory results remain higher than other hair testing matrices
● PT materials in authentic hair samples are stable ● Laboratory preparation and analytical treatment of
hair contribute to the variability of PT results
Proficiency Testing 27 July 15, 2013
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References ● Ropero-Miller J.D., Bourland J., and J.M. Mitchell. 2009. Drugs of abuse in hair.
Edited by J.D. Ropero-Miller, and B.A. Goldberger. Pp. 157–203 in Handbook of Workplace Drug Testing (2nd edition). AACC Press: Washington, DC.
● Jurado C., and H. Sachs. Proficiency test for the analysis of hair for drugs of abuse, organized by the Society of Hair Testing. Forens Sci Int 133 (2003) 175–178.
● Society of Hair Testing. www.soht.org
● Deveauxa M., Kintz P, et al. The hair analysis proficiency testing program of the French Society of Analytical Toxicology. Forens Sci Int 107 (2000) 389–394.
● Pichini S, Ventura M, et al. HAIRVEQ: an external quality control scheme for drugs of abuse analysis in hair. Forens Sci Int 2004 Oct 29;145(2-3):109-15.
● M. Ventura, C. Stramesi, et al. HAIRVEQ 2006: Evolution of laboratories’ performance after different educational actions. . Forens Sci Int Mar 2008 176(1):2-8, 21.
● ARVECON GmbH. External Quality Assurance by order of the GTFCh. http://www.arvecon.com/downloads/ptgtfch2013e.pdf
Proficiency Testing 28 July 15, 2013